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Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001137
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : December 6, 2013
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Brief Summary:
The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.

Condition or disease
HIV Infections

Detailed Description:

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

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Study Type : Observational
Actual Enrollment : 5982 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol
Study Start Date : January 2000
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Successive suppressed viral load measures [ Time Frame: Measured 144 weeks after randomization ]
  2. Genotypic or phenotypic resistance [ Time Frame: Measured at baseline and study completion ]
  3. Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater [ Time Frame: Measured throughout ]
  4. Absolute number and percentage of CD4 and CD8 T cells [ Time Frame: Measured 144 weeks after randomization ]
  5. Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells [ Time Frame: Measured 144 weeks after randomization ]
  6. Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells [ Time Frame: Measured 144 weeks after randomization ]
  7. Levels of immune activation markers, including CD8, CD38, and HLA-DR cells [ Time Frame: Measured 144 weeks after randomization ]

Secondary Outcome Measures :
  1. HIV-1 latency or replication in tissue or cellular reservoirs [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ]
  2. Syncytium and non-syncytium inducing (SI/NSI) phenotype [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ]
  3. Metabolic and neurologic complications [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ]
  4. Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV [ Time Frame: Measured 144 weeks after randomization ]
  5. Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs) [ Time Frame: Measured at baseline, Week 16, and study completion ]
  6. Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities [ Time Frame: Measured at baseline, Week 48, and study completion ]
  7. Quality of life scores [ Time Frame: Measured at baseline, Week 48, and study completion ]
  8. Subject-reported patterns of adherence [ Time Frame: Measured at baseline, Week 48, and study completion ]
  9. Estimated inpatient, outpatient, and total costs [ Time Frame: Measured at study completion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants in this study will be HIV-infected men and women who are enrolled in an ACTG parent study and are receiving HAART.

Inclusion Criteria

  • HIV-1 infected
  • Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study, including the visit window of the parent study. More information on this criterion can be found in the protocol.
  • Willing to provide consent for the release and use of clinical data from the parent study
  • Life expectancy of at least 24 weeks
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria

  • Active alcohol or drug abuse that may interfere with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001137

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Sponsors and Collaborators
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Constance A. Benson, MD Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
Study Chair: Ann C. Collier, MD University of Washington
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: AIDS Clinical Trials Group Identifier: NCT00001137    
Other Study ID Numbers: ACTG A5001
1U01AI068636 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by AIDS Clinical Trials Group:
Treatment Experienced
Treatment Naive
Virus Replication
AIDS-Related Opportunistic Infections
Risk Factors
RNA, Viral
Anti-HIV Agents
Viral Load
Nervous System
Cardiovascular System
Neurologic Symptoms
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases